Occlusion device and associated deployment method

ABSTRACT

An occlusion device for occluding a cavity defined by a body is provided, and includes first and second laterally-expandable portions each formed of a woven tubular fabric and having opposed proximal and distal ends. The first portion is insertable into the cavity so as to be substantially disposed therein upon lateral expansion thereof. A connective element tethers the distal end of the first portion and the second portion, and is cooperable therewith to form a collapsible assembly extending along an insertion axis. Retention members, operably engaged with each of the first and second portions and spaced apart about a laterally outward surface thereof, are adapted to engage the body, after insertion of the collapsed assembly, second portion-first, into the cavity, and subsequent lateral expansion of the first and second portions, so as to retain the assembly substantially within the cavity. An associated deployment method is also provided.

BACKGROUND OF THE DISCLOSURE

1. Field of the Disclosure

Aspects of the present disclosure are directed to implantable medicaldevices, more particularly to implantable medical devices configured toocclude vessels, cavities, appendages, or the like, within a body, anddeployment methods associated therewith.

2. Description of Related Art

A variety of devices and/or techniques, along with materials for andmethods of manufacturing such devices, have been developed to occlude avessel or an opening in an organ (e.g., heart) of a patient.

Such devices, however, may not be particularly suited to addressspecific physiological conditions such as, e.g., occlusion of the leftatrial appendage (LAA), in order to reduce the risk of embolisms whenthe patient is undergoing atrial fibrillation. During atrialfibrillation, the left atrial appendage may be a significant source ofthe undesirable formation of thrombus-embolis. Also, occlusion of theleft atrial appendage by surgical techniques may not always be possibleand/or advisable. Further, some such devices applied to occlude the leftatrial appendage may sometimes be at risk of being undesirably expelledfrom the left atrial appendage due to, e.g., forces generated by atrialfibrillation. In addition, some such devices may be configured so as toundesirably prevent some subsequent alternate treatments of thecondition such as, e.g., ablation therapy for atrial fibrillation.

As such, there exists a need for an occlusion device and associateddeployment method capable of addressing the above-noted and otherfactors involved in therapies for atrial fibrillation of the left atrialappendage and/or other vessels, cavities, appendages, or the like,within the body.

BRIEF SUMMARY OF THE DISCLOSURE

The above and other needs are met by aspects of the present disclosurewhich, in one aspect, provides an occlusion device adapted to bereceived within and to occlude a cavity defined by a body, wherein thebody comprises tissue forming a rim defining an opening extending intothe cavity. Such an occlusion device comprises a firstlaterally-expandable portion formed of at least one metal strand woveninto at least one layer of a tubular fabric, and having opposed proximaland distal ends. The first portion is configured to be insertable intothe cavity through the opening so as to be substantially disposed withinthe cavity upon lateral expansion thereof. A second laterally-expandableportion is formed of at least one metal strand woven into at least onelayer of a tubular fabric, wherein the second portion has opposedproximal and distal ends and is configured to be insertable into thecavity distally to the first portion. A connective element is operablyengaged with and tethers the distal end of the first portion to thesecond portion, and is cooperable therewith to form a collapsibleassembly extending along an insertion axis. A plurality of retentionmembers may be operably engaged with at least one of the first andsecond portions, and the retention members may be spaced apart about alaterally outward surface thereof. The retention members may be adaptedto engage the body, upon insertion of the collapsible assembly, in acollapsed state and with the second portion first inserted distally tothe first portion, into the cavity along the insertion axis, and uponsubsequent lateral expansion of the first and second portions, so as toretain the assembly within the cavity.

Another aspect of the disclosure is directed to a method of deploying anocclusion device into and to occlude a cavity defined by a body, whereinthe body comprises tissue forming a rim defining an opening extendinginto the cavity. Such a method comprises inserting a collapsed occlusionassembly along an insertion axis thereof into the cavity through theopening, wherein the occlusion assembly has a leading end and a trailingend. Such an assembly includes a first laterally-expandable portionformed of at least one metal strand woven into at least one layer of atubular fabric and having opposed proximal and distal ends, wherein thefirst portion is disposed toward the trailing end. A secondlaterally-expandable portion is formed of at least one metal strandwoven into at least one layer of a tubular fabric and has opposedproximal and distal ends, wherein the second portion is disposed towardthe leading end. A connective element is operably engaged with andtethers the distal end of the first portion to the second portion. Aplurality of retention members may be operably engaged with each of thefirst and second portions, and the retention members may be spaced apartabout a laterally outward surface thereof. The assembly is thenactuated, wherein the first and second portions thereof are responsiveto the actuation so as to laterally expand to engage the body definingthe cavity, such that the retention members engage the body to retainthe assembly substantially within the cavity.

Aspects of the present disclosure thus address the identified needs andprovide other advantages as otherwise detailed herein.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)

Having thus described the disclosure in general terms, reference willnow be made to the accompanying drawings, which are not necessarilydrawn to scale, and wherein:

FIG. 1 schematically illustrates an occlusion device, according to oneaspect of the present disclosure;

FIG. 2 schematically illustrates an occlusion device, according to oneaspect of the present disclosure, inserted into and deployed in anexemplary bodily cavity;

FIGS. 3A and 3B schematically illustrate side and front elevations,respectively, of an occlusion device according to another aspect of thepresent disclosure, inserted into and deployed in an exemplary bodilycavity;

FIGS. 4A and 4B schematically illustrate cross-sectional and frontelevations, respectively, of an occlusion device according to anotheraspect of the present disclosure, inserted into and deployed in anexemplary bodily cavity; and

FIG. 5 schematically illustrates a cross-sectional elevation of anocclusion device according to another aspect of the present disclosure,inserted into and deployed in an exemplary bodily cavity.

DETAILED DESCRIPTION OF THE DISCLOSURE

The present disclosure now will be described more fully hereinafter withreference to the accompanying drawings, in which some, but not allaspects of the disclosure are shown. Indeed, the disclosure may beembodied in many different forms and should not be construed as beinglimited to the aspects set forth herein; rather, these aspects areprovided so that this disclosure will satisfy applicable legalrequirements. Like numbers refer to like elements throughout.

Aspects of the present disclosure provide a medical device for use intreating a target site within the body, such as occluding variousvascular abnormalities, which may include, for example, occluding a LeftAtrial Appendage (LAA), an Arterial Venous Malformation (AVM), a PatentDuctus Arteriosus (PDA), or the like. It is understood that the use ofthe term “target site” is not meant to be limiting, as the device may beconfigured to treat any target site, such as an abnormality, a vessel,an organ, an opening, a chamber, a channel, a hole, a cavity, or thelike, located anywhere in the body. For example, the abnormality couldbe any abnormality that affects the shape or the function of the nativelumen, such as an aneurysm, a congenital defect, a vessel dissection,flow abnormality or a tumor. Furthermore, the term “lumen” is also notmeant to be limiting, as the abnormality may reside in a variety oflocations within the vasculature, such as a vessel, an artery, a vein, apassageway, an organ, a cavity, a septum, or the like.

According to one aspect of the present disclosure for forming a medicaldevice, the device includes one or more layers of braided fabric,wherein each layer may be formed of at least one wire strand woven intoa tubular fabric, or a plurality of filaments having a predeterminedrelative orientation with respect to one another. Moreover, the devicemay comprise a plurality of layers of occluding material such that thedevice may be a variety of occluding materials capable of at leastpartially inhibiting blood flow therethrough in order to facilitate theformation of thrombus and epithelialization around the device.

Although the term “strand” is discussed herein, “strand” is not meant tobe limiting, as it is understood the fabric may comprise one or morewires, cords, fibers, yams, filaments, cables, threads, or the like,such that such terms may be used interchangeably. As used herein theterm “proximal” shall mean closest to the operator (less into the body)and “distal” shall mean furthest from the operator (further into thebody). In positioning of the medical device from a downstream accesspoint, distal is more upstream and proximal is more downstream.

According to one aspect, the occlusive material may be a metal fabricincluding a plurality of strands, wherein at least one strand may be ametal strand, such as two sets of essentially parallel generally helicalstrands, with the strands of one set having a “hand”, i.e., a directionof rotation, opposite that of the other set. The strands may be braided,interwoven, or otherwise combined to define a generally tubular fabric.The pitch of the strands (i.e., the angle defined between the turns ofthe strands and the axis of the braid) and the pick of the fabric (i.e.,the number of wire strand crossovers per unit length) may be adjusted asdesired for a particular application. The at least one wire strand ofthe metal fabric used in aspect of the present disclosure may be formedof a material that is both resilient and can be heat treated tosubstantially set a desired shape. One factor in choosing a suitablematerial for the at least one wire strand is that the wire(s) retain asuitable amount of the deformation induced by the molding surface (asdescribed herein) when subjected to a predetermined heat treatment andelastically return to said molded shape after substantial deformation.

FIGS. 1 and 2 are schematics of an exemplary occlusion device 100according to one aspect of the present disclosure. In such an aspect,the occlusion device 100 may be adapted to be received within and toocclude a cavity 200 defined by a body 225, wherein the body 225comprises tissue forming a rim portion 250 defining an opening 275extending into the cavity 200 and having a circumference. Such a cavity200 may comprise, for example, the left atrial appendage (LAA) of theheart. In some instances, the occlusion device 100 may comprise firstand second laterally-expandable portions 300, 400, wherein each portionmay be formed of at least one metal strand woven or braided into atleast one layer of a tubular fabric, and a connective element 500extending therebetween and tethering the first and second portions 300,400 together. In so being formed, such first and secondlaterally-expandable portions 300, 400 may each include opposed proximalends 300A, 400A, and distal ends 300B, 400B, respectively. One skilledin the art will appreciate, however, that even though the disclosureherein references an occlusion device comprising first and secondportions, and a connective element therebetween, such a configuration isfor exemplary purposes only and that an occlusion device according toother aspects of the disclosure may comprise three or more separate anddiscrete portions configured to be cooperable according to the variousprinciples herein disclosed.

Both the first and second portions 300, 400 may be configured to beinsertable into the cavity 200 through the opening 275. Further, in someinstances, as shown, for example, in FIG. 2, at least the first portion300 is configured to minimally outwardly-extend from the cavity 200 pastthe rim portion 250, either laterally and/or longitudinally, uponlateral expansion of the first portion 300. That is, the occlusiondevice 100, or at least the first portion 300 thereof, may be configuredso as to be substantially disposed within the cavity 200 upon lateralexpansion thereof, and/or when the first portion 300 is laterallyextended to engage the tissue defining the wall of the cavity 200, theproximal end 300A of the first portion 300 may be substantially flushwith or juxtaposed with the rim portion 250 defining the opening 275. Aconnective element 500 may be operably engaged with and configured totether the distal end 300B of the first portion 300 to the secondportion 400. In some instances, the connective element 500 may beconfigured to tether the distal end 300B of the first portion 300 withthe proximal end 400A of the second portion 400. The engagement betweenthe connective element 500 and the respective first and second portions300, 400 may be configured such that each of the first and secondportions 300, 400 is articulable, rotatable, flexible, or otherwisemovable with respect to the connective element 500. In cooperation, thefirst and second portion 300, 400, and the connective element 500, maybe configured to form an axially and/or radially collapsible assembly(occlusion device 100) extending along an insertion axis 600 (otherwisereferred to herein as a longitudinal device axis, defined by theexemplary occlusion device 100 assembly, including the first and secondportions 300, 400 and the connective element 500). Further, each of thefirst and second portions 300, 400 may define a respective longitudinalaxis 300C, 400C. In such instances, the occlusion device 100 assemblymay be further configured to be insertable into the cavity 200, alongthe insertion axis 600, with the second portion 400 first inserted intothe cavity 200, followed by the connective element 500, and then thefirst portion 300.

Once inserted into the cavity 200, the occlusion device 100 may bedeployed and retained therein by a plurality of retention members 700operably engaged with at least one of the first portion 300 and thesecond portion 400. In some instances, the retention members 700 may beoperably engaged with each of the first and second portions 300, 400. Insuch instances, as will be appreciated by one skilled in the art, theretention members engaged with the first portion 300 may not necessarilybe the same as the retention members engaged with the second portion 400(i.e., one set of the retention members may be configured to be morerobust to engage a smoother cavity surface, while the other set orretention members may be configured to be relatively less robust toengage a rougher cavity surface). According to some aspects, theretention members 700 are adapted to engage the body 225, afterinsertion of the collapsible assembly 100, in a collapsed state and withthe second portion inserted first, into the cavity 200 along theinsertion axis 600, and upon subsequent lateral expansion of thecorresponding first and/or second portions 300, 400 having the retentionmembers 700 operably engaged therewith, so as to retain the assembly 100within the cavity 200. More particularly, each retention member 700 maybe configured to be non-piercing with respect to the body 225 definingthe cavity 200, and to extend at an acute angle from an outer peripheralsurface of the respective one of the first and second portions, 300,400, in a direction toward the proximal end thereof, so as to providethe securement of the first and/or second portions 300, 400 within thecavity 200. In some instances, the retention members 700 may be disposedin a spaced-apart manner about an outer circumference of the firstand/or second portions 300, 400. In some aspects, the second portion400, when laterally expanded, has a lateral dimension no greater thanthe maximum lateral dimension of the first portion 300, when laterallyexpanded.

In some aspects, the first portion 300, the second portion 400, and/orthe connective element 500 of the occlusion device 100 may be formed ina mesh-like or otherwise porous configuration (such as, e.g., woven,braided, or helically wound or braided, from one or more strands into atleast one layer of a fabric, in some instances, from one or moremetallic strands into at least one layer of a tubular fabric), such thatthe first portion 300, the second portion 400, and/or the connectiveelement 500 define openings or pores extending from the exteriorsthereof to respective, generally hollow, interiors. The first portion300, the second portion 400, and/or the connective element 500 may becomprised of a material having a shape memory property and/or asuperelastic property. More particularly, such a material shoulddesirably be both resilient and capable of being formed into a desiredshape. Accordingly, in instances where the first portion 300, the secondportion 400, and/or the connective element 500 are comprised of at leastone strand of a metallic material, the at least one metal strand maycomprise an appropriate metallic material such as, for example, astainless steel alloy, a nickel-titanium alloy, or acobalt-chromium-nickel alloy. More particularly, some exemplary suitablematerials include a cobalt-based low thermal expansion alloy such asElgeloy™, nickel-based high temperature high-strength “superalloys”commercially available from Haynes International under the trade nameHastelloy™ nickel-based heat treatable alloys sold under the nameIncoloy™ by International Nickel, and a number of different grades ofstainless steel.

One particular type of suitable material which may also meet thesequalifications includes shape memory alloys such as Nitinol™, anapproximately stoichiometric alloy of nickel and titanium. Such alloysmay tend to exhibit a temperature-induced phase change which will causethe material to have a preferred configuration, wherein such a preferredconfiguration may be set by heating the material above a certaintransition temperature to induce the phase change in the material. Thatis, the material may be held/maintained in the preferred shape (i.e., byplacement of the fabric in an appropriate mold representing the desiredrelaxed/expanded shape of the final product) during the heat treatmentprocess. When the material is cooled to below the transition temperatureand removed from the mold, the alloy will “remember” the preferredconfiguration maintained during the heat treatment and will tend torevert to that configuration, unless otherwise constrained from doingso. Such shape memory alloys may also exhibit high elasticity, and maysometimes be referred to as “superelastic” or “pseudoelastic.” Oneskilled in the art will appreciate, however, that these exemplary metalalloys/materials are not intended to be limiting in any manner withrespect to the configuration of the first portion 300, the secondportion 400, and/or the connective element 500 of the occlusion device100 disclosed herein.

In one example, the first portion 300, the second portion 400, and/orthe connective element 500 may be formed from at least one metal strandhaving a diameter of between about 0.001 inches and about 0.015 inches,preferably between about 0.003 inches and about 0.0045 inches, whereinthe resulting tubular fabric may comprise between about 72 and about 144such strands. In another example, the first portion 300, the secondportion 400, and/or the connective element 500 may be formed from 72braided Nitinol™ wires or strands having a diameter ranging betweenabout 0.002 inches and about 0.006 inches (between about 0.051 mm andabout 0.154 mm), but particularly, in some instances, between about0.003 inches and about 0.005 inches (between about 0.077 mm and about0.128 mm). In some instances, the first portion 300, second portion 400,and/or connective element 500 may comprises more than one layer offabric, wherein in such instances, the metal strand diameter may rangefrom between about 0.0015 inches and about 0.0035 inches in at least oneof the layers. In some aspects, the strands may have multiple diameterswithin the same fabric, wherein the larger diameter strands may providestructural support, while the smaller diameter strands may provide forsmaller openings or pores. The number of wires/strands to be braided mayrange between about 4 strands and about 288 or more strands, butparticularly, in some instances, between about 32 strands and about 144strands and, more particularly, between about 72 strands and about 144strands, depending on the particular device characteristics desired. Insome instances, the first portion 300, second portion 400, and/orconnective element 500 may comprises more than one layer of fabric,wherein in such instances, the number of strands forming a given layermay be the same, or different, with respect to the number of strand usedto form another layer. In some aspects, the first portion 300, thesecond portion 400, and/or the connective element 500 may be formed froma single length or strand of the braided metal fabric, wherein thelength/strand is continuous from end to end of the occlusion device 100.A pitch angle of the at least one strand in the weave, as braided, maybe on the order of between about 30 degrees and about 70 degrees withrespect to the longitudinal axis 300C, 400C of the respective firstand/or second portion 300, 400 (with the respective portion in alaterally expanded state and, in particular instances, prior to heattreatment or heat setting thereof). One skilled in the art willappreciate, however, that various factors such as, for example, pitchangle of the at least one strand, pick count (number of strand/wirecrossovers per inch of length, or other lineal measure), and/orstrand/wire diameter, may be altered, as necessary or desired, to obtainappropriate device characteristics and/or the heat set shape.

The aspect of the occlusion device 100 illustrated in FIGS. 1 and 2shows the first and second portions 300, 400 in their respectivelaterally- or radially-expanded (i.e., relaxed) states. That is, thefirst portion 300, the second portion 400, and/or the connective element500 may be configured so as to be self-expanding, particularly in aradial direction. More particularly, in some instances, the at least onestrand woven into a tubular fabric may be configured such that axialtension applied to the tubular fabric (i.e., about the ends thereof)causes the tubular fabric to experience a reduction in cross-sectionaldimension (i.e., diameter). Such reduction in cross-sectional dimension,in some instances, in conjunction with axial lengthening of the tubularfabric, may also be achieved by radially compressing the tubular fabricperpendicular to the axis thereof. In some instances, the woven tubularfabric may comprise more than one layer (i.e., the tubular fabric may befolded back over itself, or multiple separate layers may beconcentrically arranged and secured together).

In one particular example, each layer of the first portion 300, thesecond portion 400, and/or the connective element 500 may be formed as atubular “braid” comprised of one or more individual strands of Nitinol™wire wound helically, and crossing over itself or one another. The wovennature of the braid holds the wires of each layer together. In formingthe first portion 300, the second portion 400, and/or the connectiveelement 500 of the occlusion device 100, an appropriately-sized(lengthwise) portion of the tubular fabric may be cut from a longersection thereof. In some aspects, the first and/or second portions 300,400 may be configured such that the maximum lateral dimension of thefirst and/or second portion 300, 400, when laterally expanded, isbetween about 1.5 and about 5 times the length along the respective axisbetween the proximal and distal ends thereof. When the tubular fabric iscut, the respective axial ends typically must be addressed in order toprevent the woven/braided material from unraveling. As such, in someinstances, upon or prior to cutting the tubular fabric to form the firstportion 300, the second portion 400, and/or the connective element 500,the opposing axial ends of each cut portion may be sealed or otherwisesecured to prevent such unraveling, for example, by soldering, brazing,welding, or other process by which the severed strand(s) can be fixedtogether. In one example, a biocompatible cementitious organic materialmay be applied to an appropriate location of the longer length of thetubular fabric, before the tubular fabric is cut to form the firstportion 300, the second portion 400, and/or the connective element 500.One skilled in the art will appreciate, however, that the strands aboutthe respective ends of the first portion 300, the second portion 400,and/or the connective element 500 may be held together to preventunraveling through many other mechanisms known or later developed in theart. For example, besides welding or the use of adhesives to secure theends of the braided tubular fabric, mechanical or other securementdevices such as clamps or connectors may also be applied so as toprevent unraveling of the respective component and/or to allow therespective one of the first portion 300, the second portion 400, and/orthe connective element 500, for instance, to be connected to an adjacentcomponent, such as a deployment tool (i.e., the vascular catheterdevice) and/or the connective element 500 by way of a threadedengagement. For example, an end of the tubular fabric, such as theproximal end 300A of the first portion 300, may be engaged with asecurement device so as to prevent the tubular fabric from unraveling,while a threaded configuration, for example, allows the securementdevice to releasably engage a delivery device configured to insert theocclusion device 100 assembly into the cavity 200. One skilled in theart will appreciate, however, that many other configurations ofcomplementary components could be used in place of threads to facilitatethe releasable engagement and deployment of the occlusion device 100such as, for example, grooves, slots, tethers, etc.

In some instances, the tubular layers of the braided Nitinol™ wire(fabric) may be concentrically arranged with respect to one another on aforming mold, and the assembly may then be heat set to hold the tubularconfiguration. In such instances, one relevant property of the woventubular fabric, thus formed, may be a radial expansive force that may beexerted thereby. For example, the woven tubular fabric may be heat setto form each of the first and second portions 300, 400 with a respectivelaterally-expanded diameter of between about 10% and about 30% largerthan the diameter about the longitudinal position within the cavity forwhich the first and second portions 300, 400 are intended. That is, theradial expansive force exerted by the fabric upon radial expansionthereof facilitates retention of the device or device portion, in itsdeployed configuration, within the cavity in which it is inserted byexerting a biasing force against the tissue defining the cavity 200.Such retention of the tubular fabric within the cavity may also befacilitated by the retention members engaged with the device or deviceportions and interacting with the bodily wall defining the cavity. Theconnective element 500, upon formation thereof, may be heat set so as tohave a relatively small expanded diameter as compared to the firstand/or second portions 300, 400 so as to facilitate flexibility betweenthe respective portions 300, 400 of the occlusion device 100 and theconnective element 500.

In one aspect, at least one of the woven fabrics/fabric layers maydefine openings in the weave that are between about 0.0015 square inchesand about 0.0003 square inches, which may sufficiently/relatively smallso as to substantially preclude or impede flow therethrough. It shouldbe noted that, as used herein, the phrase “substantially preclude orimpede flow” shall indicate, functionally, that blood flow may occur fora short time, preferably between about 15 minutes and about 45 minutes,but that the body's clotting mechanism or the presence of protein orother deposits on the braided fabric, may result in occlusion or flowstoppage through the fabric after the initial period. This may beclinically represented, for example, by no contrast flow through thefabric after the 15-45 minute period as viewed by a fluoroscopyprocedure after a contrast injection.

In some instances, the deployed fabric may endothelialize within thecavity and become incorporated into the bodily wall defining the cavity.In order to further encourage occlusion and thrombosis, and thereafterendothelialization, the woven tubular fabric may have at least oneoccluding fiber associated therewith. The at least one occluding fibermay be, for example, woven into a tubular fabric so as to form oneconcentric layer with the first and/or second portions 300, 400. Inanother example, the at least one occluding fiber may be woven into thefirst and/or second portion 300, 400. In yet another example, a polymerfabric may be secured, for example, by suturing, to the braided metalfabric. In various aspects, the at least one occluding fiber may bewoven with the at least one metal strand, may be a fabric attached tothe at least one layer of the tubular fabric, and/or may be a discretewoven tubular fabric concentrically-disposed with respect to the atleast one layer of the tubular fabric.

In order to facilitate insertion thereof into the cavity 200, theocclusion device 100 may be altered from the laterally-expanded presetconfiguration into an axially-elongated, reduced lateral dimensionconfiguration. For example, the first and second portions 300, 400 ofthe occlusion device 100 may be inserted into a vascular catheter in theaxially-elongated, reduced lateral dimension configuration, for vasculardelivery to a treatment site, wherein the occlusion device 100 can thenbe deployed from the catheter to return to the expanded presetconfiguration of the first and/or second portions 300, 400 (and, in someinstances, the flange 325, as disclosed hereinbelow) thereof, in orderto form an occlusion, flow restriction or shunt in the cavity 200defined by a body organ, such as the LAA, or other vessel. To form aflow restrictor or shunt, an axial flow path through the fabric and/orthe device or device portions may be sized and shaped, for example, by aheat set molding process similar to or simultaneously with the processused to form the first portion 300, the second portion 400, and/or theconnective element 500, as previously disclosed. In one aspect, theocclusion device 100 may be configured to be insertable into the cavity200 through the opening 275 so as to not extend, laterally orlongitudinally, from the cavity 200, past the rim portion 250 thereof,upon lateral expansion of at least the first portion 300 and securementthereof in the cavity 200. That is, the occlusion device 100 may beconfigured such that, upon deployment, the occlusion device 100, or atleast the first portion 300 thereof, may be substantially disposedwithin the cavity 200 and/or such that the proximal end 300A of thefirst portion 300 is juxtaposed with the rim portion 250 of the cavity200.

In other aspects, as shown in FIGS. 3A and 3B, at least the firstportion 300 of the occlusion device 100 may include a flange 325operably engaged or integrally formed therewith. In some instances, theflange 325 may be configured to be articulable with respect to the firstportion 300. In some particular instances, such a flange 325 may beengaged or integrally formed with the proximal end 300A of the firstportion 300. The first portion 300 has a lateral dimension (i.e., width)measured transverse to and through the longitudinal axis 300C thereof.If the desired expanded preset configuration of the first portion 300 istubular with a circular cross-section, the lateral dimension between theproximate and distal ends 300A, 300B thereof may be substantiallyconstant. In some aspects, the first and/or second portions 300, 400 mayhave a substantially circular laterally-expanded cross-section. In otherinstances, the lateral dimension of the first and/or second portions300, 400 may vary, as necessary or desired, between the respectiveproximal and distal ends, whether in cross-sectional shape or profileshape. For example, the tubular first and/or second portions 300, 400may be configured with square-, elliptical-, oval-, hexagonal-, or anyother suitable polygonal-shaped cross-section. In one instance, as shownin FIGS. 3A and 3B, the flange 325 may have an oval configuration. Insome instances, a flange connective element 350 may be configured totether the flange 325 to the first portion 300, for example, similarlyto the manner in which the connective element 500 tethers the firstportion 300 to the second portion 400. The flange 325 and/or the flangeconnective element 350 may be formed of at least one metal strand formedinto at least one layer of a woven fabric. The flange 325 may have arelaxed expanded preset shape extending laterally outward past the rimportion 250 in such a manner as to overlap the circumference of the rimportion 250, in total, for less than one of one-half of thecircumference of the rim portion 250, one-third of the circumference ofthe rim portion 250, and one-fourth of the circumference of the rimportion 250. The flange 325 may be configured to minimally engage thetissue forming the rim portion 250 and thus function as a stop orlocator to facilitate proper positioning of the occlusion device 100longitudinally/axially relative to the opening 275 of the cavity 200. Ina similar manner to the connective element 500, the flange connectiveelement 350 may likewise be heat set to a relatively small diameter inrelation to the diameter of the first portion 300 so as to, for example,facilitate flexibility between the flange 325 and the first portion 300.The flange 325 and flange connective element 350 may be formed of thesame fabric as the first and/or second portions 300, 400 and/or theconnective element 500, wherein such a single fabric may, in someinstances, extend from a proximal end of the occlusion device 100 to thedistal end of the occlusion device 100. That is, in some aspects, thefirst and second portions 300, 400 and the connective element 500 may beformed from at least one contiguous layer of the tubular fabric. Inother aspects, the first and second portions 300, 400, the connectiveelement 500, the flange 325, and the flange connective element 350 maybe formed from at least one contiguous layer of the tubular fabric.

As shown in FIG. 5, the flange 325 engaged with the proximal end 300A ofthe first portion 300, in some aspects via a flange connective element350, may facilitate or otherwise allow the first portion 300 to beinserted further into the cavity 200, if necessary or desired. In someinstances, the flange 325 may be configured to have at least one lateraldimension greater than a lateral dimension of the opening 275 defined bythe rim portion 250, even in instances where the engagement between thefirst portion 300 and the body 225 defining the cavity 200 causes theopening 275 to laterally expand. In such instances, in accordance withsome aspects of the present disclosure, the flange 325 may also beconfigured so as to not completely cover the opening 275, to minimallyengage the tissue forming the rim portion 250, or otherwise beconfigured to have an interference relationship with respect to thetissue forming the rim portion 250. That is, the flange 325 may extendperpendicularly to the longitudinal axis 300C of the first portion 300,past the maximum lateral dimension thereof when radially expanded, suchthat at least a portion thereof laterally extends to a dimension greaterthan the lateral dimension of the rim portion 250 defining the opening275. The flange 325 may thus be configured to engage the rim portion250, but preferable does so without completely overlapping the opening275 (i.e., overlapping or otherwise interfering with the circumferenceof the rim portion 250, in total, for less than one of one-half of thecircumference of the rim portion 250, one-third of the circumference ofthe rim portion 250, and one-fourth of the circumference of the rimportion 250). For example, in some aspects, the flange 325 may beconfigured or otherwise shaped as an oval, whereby the major dimensionof the oval extends to a dimension greater than the lateral dimension ofthe opening 275, and the minor dimension of the oval is less than thelateral dimension of the opening 275. Accordingly, when viewed along theinsertion axis 600, the flange 325 will overlap the circumference of therim portion 250 by a relatively small portion of the circumferencethereof, thus forming a minimal engagement with the tissue forming therim portion 250.

One skilled in the art will appreciate, however, that the flange 325 maybe configured in many different manners so as to extend laterally oroverlap only a relatively small portion of the tissue forming the rimportion 250 defining the opening 275, when the occlusion device 100 isdeployed. For example, the flange 325 may be configured to be shaped asa “cross” of two intersecting elongate members. In some instances, theflange 325 associated with the first portion 300 may prevent theocclusion device 100 from being inserted/deployed too deeply in thecavity 200, or otherwise to cause the flange 325 and/or proximal end300A of the first portion 300 to be substantially flush or otherwisejuxtaposed with the tissue forming the rim portion 250 defining theopening 275. In other instances, the flange 325 may be configured not toentirely cover the opening 275. In any instances, aspects of theocclusion device 100 disclosed herein may allow othertreatments/therapies to be subsequently applied to or about the affectedbody 225, without requiring the deployed occlusion device to be firstremoved (where such subsequent treatment/therapy may be otherwiseprecluded by a deployed occlusion device 100 having a flange coveringthe entire opening or otherwise overlapping a major portion of the rimportion 250). Such a subsequent treatment/therapy may be, for example,ablation therapy, wherein at least some of the rim portion 250 may beablated to treat the atrial fibrillation condition. One skilled in theart will thus appreciate that the “flangeless” aspect of the occlusiondevice 100, or the “minimally-engaging” flange aspect, previouslydisclosed may also facilitate such subsequent treatments/therapies.

In some aspects, the flange may comprise a plurality of flange members330 (see, e.g., FIGS. 4A and 4B), each extending laterally from theproximal end 300A of the first portion 300 and spaced apart thereabout.In such instances, the plurality of flange members 330 may be integrallyformed with the first portion 300 or may otherwise be attached thereto.Further the plurality of flange members 330 may also be configured suchthat at least two of the flange members 330 cooperate to have a lateraldimension greater than a lateral dimension of the opening 275 defined bythe rim portion 250. The flange members 330 may also be configured tocooperate to overlap the circumference of the rim portion 250, in total,for less than one of one-half of the circumference of the rim portion250, one-third of the circumference of the rim portion 250, andone-fourth of the circumference of the rim portion 250. Similarly to thesingle flange 325, the plurality of flange members 330 may be configuredto facilitate longitudinal/axial placement of the occlusion device 100within the cavity 200, such that the proximal end 300A of the firstportion 300 is nearly flush with the rim portion 250 and/or juxtaposedtherewith, and the occlusion device 100 is substantially disposed withinthe cavity 200. In this regard, one skilled in the art will appreciatethat the size, shape and number of flange members 330 may be varied asnecessary or desired.

According to another aspect of the present disclosure, the occlusiondevice 100 may also be configured to be laterally and/or axiallycollapsible so as to facilitate insertion thereof into the cavity 200and/or subsequent deployment. In such instances, the first portion 300,the second portion 400, and/or the connective element(s) 350, 500 may beconfigured to facilitate such lateral collapsibility. For example, thefirst portion 300, the second portion 400, and/or the connectiveelement(s) 350, 500 may be braided such that an axial tension forceapplied thereto causes the first portion 300, the second portion 400,and/or the connective element(s) 350, 500 to radially or laterallycontract. In other aspects, the first portion 300, the second portion400, and/or the connective element(s) 350, 500 may be configured tofacilitate an enhanced securing force (i.e., a laterally-outward biasingforce for facilitating engagement between the retention element(s) 700and the body 225 defining the cavity 200) and/or flexibility orarticulability between the flange 325, the first portion 300, the secondportion 400, and/or the connective element(s) 350, 500. For example, atleast the distal end 300B of the first portion 300 and/or at least theproximal end 400A of the second portion 400 may be configured to beconcave (see, e.g., FIG. 5), wherein such concavities may be configuredto receive at least a portion of the connective element 500, so as tofacilitate flexibility and/or articulation between the variouscomponents of the occlusion device 100 assembly (i.e., in the lateral(radial) and/or longitudinal (axial) direction). In this regard, theconnective element 500 may be configured to have a lateral dimensionsmaller than the lateral dimension of the first and second portions 300,400. The connective element 500 may also have a length of less than thelength of the first and/or second portions 300, 400, and may also beconfigured to have a length to lateral dimension ratio of between about2 and about 30. Further, the connective element 500 may be configuredsuch that a ratio of the maximum lateral dimension of each of the firstand second portions, 300, 400, when laterally expanded, to the lateraldimension of the connective element 500, is between about 5 and about30. In addition, each of the first and second portions 300, 400 may bearticulable, rotatable, or otherwise movable with respect to theconnective element 500, and the connective element 500 may also beconfigured to be flexible. One skilled in the art will also appreciatethat the proximal end 300A of the first portion 300 and/or the distalend 400B of the second portion 400 may also be configured to be concaveso as to, for instance, receive the respective securement device(s)securing these ends of the first and second portions 300, 400, and/orsecuring the flange 325 to the first portion 300. In addition, theflange 325 and/or the proximal end 300A of the first portion 300 may beappropriately configured so as to be substantially flush and/orjuxtaposed with the rim portion when the occlusion device 100 isdeployed. In addition, the proximal and/or distal ends of the first andsecond portions 300, 400 may be configured in many different mannerssuch as, for example, substantially planar, convex, concave, etc.

Method aspects of the present disclosure may advantageously involvedeployment of the occlusion device 100 in a left atrial appendage of aheart, particularly a human heart. When deployed, it may be preferredthat the distal end 400B of the second portion 400 of the occlusiondevice 100 faces an interior or end of the left atrial appendage andthat the proximal end 400A faces the distal end 300B of the firstportion 300, as well as the opening 275 into the left atrial appendage,while the proximal end 300A of the first portion 300 faces away from thesecond portion 400 toward the opening 275. If the first portion 300 doesnot include a flange 325, the occlusion device 100 is preferablyinserted into the left atrial appendage such that the proximal end 300Aof the first portion 300 is substantially disposed within the cavity 200and flush and/or juxtaposed with the rim portion 250, or otherwise suchthat the first portion 300 minimally extends therefrom, laterally and/orlongitudinally, past the rim portion 250, upon expansion and securementthereof by the retention devices 700 within the LAA.

In some instances, the occlusion device 100 may be connected to orotherwise engaged with a delivery device (not shown), for example, byway of a threaded connection therebetween. The delivery device may be anelongated member extending from the occlusion device 100 to a locationoutside the body for axial position control of the occlusion device 100maintained in a collapsed state within a delivery catheter lumen. Assuch, in some instances, if a misplacement of the occlusion device 100may occur during deployment, it may be possible for the occlusion device100 to be withdrawn by the delivery device into the delivery catheterlumen and re-positioned, as necessary, prior to re-deployment. If theocclusion device 100 does include a flange 325 or flange members 330associated with the first portion 300, the occlusion device 100 ispreferably inserted into the left atrial appendage such that the flange325 or flange members 330 minimally overlap the rim portion 250, withoutentirely covering the circumference thereof, upon expansion andsecurement of the occlusion device 100 by the retention devices withinthe LAA. Once the occlusion device 100 has been deployed, properlypositioned, and secured, the delivery device may be removed, forexample, by undoing the threaded connection therebetween. In anyinstance, one skilled in the art will appreciate that the discloseddeployment of an occlusion device within a left atrial appendage isexemplary in nature only and that aspects of the occlusion device of thepresent disclosure may be used in any opening, vessel, cavity, etc. of abody where occlusion is desired.

Many modifications and other aspects of the disclosures set forth hereinwill come to mind to one skilled in the art to which these disclosurespertain having the benefit of the teachings presented in the foregoingdescriptions and the associated drawings. Therefore, it is to beunderstood that the disclosures are not to be limited to the specificaspects disclosed and that modifications and other aspects are intendedto be included within the scope of the appended claims. Althoughspecific terms are employed herein, they are used in a generic anddescriptive sense only and not for purposes of limitation.

1-47. (canceled)
 48. An occlusion device adapted to be received withinand to occlude a cavity defined by a body, the body comprising tissueforming a rim having a circumference and defining an opening extendinginto the cavity, said occlusion device comprising: a firstlaterally-expandable portion formed of at least one metal strand woveninto at least one layer of a tubular fabric, and having opposed proximaland distal ends, the first portion being configured to be insertableinto the cavity through the opening so as to be substantially disposedwithin the cavity upon lateral expansion thereof; a secondlaterally-expandable portion formed of at least one metal strand woveninto at least one layer of a tubular fabric, the second portion havingopposed proximal and distal ends and being configured to be insertableinto the cavity distally to the first portion; a laterally-expandableconnective element formed of at least one metal strand woven into atleast one layer of a tubular fabric, the connective element beingoperably engaged with and tethering the distal end of the first portionto the second portion, and cooperable therewith to form a collapsibleassembly extending along an insertion axis; and a plurality of retentionmembers operably engaged with at least one of the first and secondportions and spaced apart about a laterally outward surface thereof, theretention members configured to be non-piercing with respect to the bodydefining the cavity and adapted to engage the body, upon insertion ofthe collapsible assembly, in a collapsed state and with the secondportion first inserted distally to the first portion, into the cavityalong the insertion axis and subsequent lateral expansion of the firstand second portions, so as to retain the assembly substantially withinthe cavity.
 49. The device according to claim 48, wherein the firstportion is configured to be insertable into the cavity through theopening such that the proximal end thereof is juxtaposed with the rimupon lateral expansion of the first portion.
 50. The device according toclaim 48, wherein the connective element is configured to have a lateraldimension smaller than a lateral dimension of the first and secondportions.
 51. The device according to claim 48, wherein the first andsecond portions are configured to be articulable with respect to theconnective element.
 52. The device according to claim 48, furthercomprising a securement device operably engaged with the proximal end ofthe first portion, the securement device being configured to engage theat least one metal strand so as to one of prevent the tubular fabricfrom unraveling, and releasably engage a delivery device configured toinsert the assembly through a delivery catheter into the cavity.
 53. Thedevice according to claim 48, wherein at least one of the first andsecond portions is comprised of a material having one of a shape memoryproperty and a superelastic property.
 54. The device according to claim48, wherein the at least one metal strand comprises a material selectedfrom the group consisting of a stainless steel alloy, a nickeltitaniumalloy, and a cobalt-chromium-nickel alloy.
 55. The device according toclaim 48, wherein each retention member extends at an acute angle fromthe respective one of the first and second portions, toward the proximalend thereof.
 56. The device according to claim 48, wherein at least oneof the first and second portions comprises an occluding fiber engagedtherewith.
 57. The device according to claim 48, wherein at least one ofthe distal end of the first portion and the proximal end of the secondportion defines a concavity configured to receive at least a portion ofthe connective element, so as to facilitate at least one of flexibilitybetween the first and second portions and biasing the plurality ofretention members into engagement with the body.
 58. The deviceaccording to claim 48, wherein at least one of the first and secondportions is configured to be substantially cylindrical when laterallyexpanded.
 59. The device according to claim 48, wherein the secondportion, when laterally expanded, has a lateral dimension less than alateral dimension of the first portion, when laterally expanded.
 60. Thedevice according to claim 48, wherein a maximum lateral dimension of oneof the first and second portions, when laterally expanded, is betweenabout 1.5 and about 15 times a length between the proximal and distalends thereof.
 61. The device according to claim 48, wherein a length ofthe connective element is less than a length of one of the first andsecond portions.
 62. The device according to claim 48, wherein theassembly is configured to be insertable into a left atrial appendage ofa heart.
 63. The device according to claim 48, wherein one of the firstand second portions is comprised of a plurality of layers of the tubularfabric.
 64. The device according to claim 48, wherein the first andsecond portions and the connective element are formed from at least onecontiguous layer of the tubular fabric.
 65. The device according toclaim 48, wherein the at least one metal strand has a diameter ofbetween about 0.002 inches and about 0.005 inches, and the tubularfabric comprises between about 36 and about 144 strands.
 66. Anocclusion device adapted to be received within and to occlude a cavitydefined by a body, the body comprising tissue forming a rim having acircumference and defining an opening extending into the cavity, saidocclusion device comprising: a first laterally-expandable portion formedof at least one metal strand woven into at least one layer of a tubularfabric, and having opposed proximal and distal ends, the first portionbeing configured to be insertable into the cavity through the opening soas to be substantially disposed within the cavity upon lateral expansionthereof; a second laterally-expandable portion formed of at least onemetal strand woven into at least one layer of a tubular fabric, thesecond portion having opposed proximal and distal ends and beingconfigured to be insertable into the cavity distally to the firstportion; and a laterally-expandable connective element having a lengthto lateral dimension ratio of between about 2 and about 30 and formed ofat least one metal strand woven into at least one layer of a tubularfabric, the connective element being operably engaged with and tetheringthe distal end of the first portion to the second portion, andcooperable therewith to form a collapsible assembly extending along aninsertion axis.
 67. An occlusion device adapted to be received withinand to occlude a cavity defined by a body, the body comprising tissueforming a rim having a circumference and defining an opening extendinginto the cavity, said occlusion device comprising: a firstlaterally-expandable portion formed of at least one metal strand woveninto at least one layer of a tubular fabric, and having opposed proximaland distal ends, the first portion being configured to be insertableinto the cavity through the opening so as to be substantially disposedwithin the cavity upon lateral expansion thereof; a secondlaterally-expandable portion formed of at least one metal strand woveninto at least one layer of a tubular fabric, the second portion havingopposed proximal and distal ends and being configured to be insertableinto the cavity distally to the first portion; and alaterally-expandable connective element formed of at least one metalstrand woven into at least one layer of a tubular fabric, the connectiveelement being operably engaged with and tethering the distal end of thefirst portion to the second portion, and cooperable therewith to form acollapsible assembly extending along an insertion axis, wherein theratio of a maximum lateral dimension of each of the first and secondportions, when laterally expanded, to a lateral dimension of theconnective element is between about 5 and about 30.